About SDIP Innovations

SDIP Innovations is an Australian medical device company, established in 2018, developing next-generation bioresorbable biomaterials for orthopaedic and regenerative medicine applications. Following recent regulatory clearance for the first application of SDIP`s proprietary technology platform, JAZBI™, we are expanding our team and seeking a motivated Senior Regulatory & Quality Affairs Specialist to support future regulatory submissions, clinical evidence programs, and market access initiatives.

About the Role

Reporting to the CEO and working closely with our Quality, R&D and Product Development teams, you will play a key role in supporting regulatory activities across multiple international markets. You will help coordinate regulatory submissions, manage technical documentation, and communicate with third-party testing laboratories, under guidance of our external consultants and US-based mentors wherever needed. You also have the chance contribute to clinical and post-market evidence generation activities for market access.

Key Responsibilities – Regulatory Affairs

• Support preparation and maintenance of regulatory submissions and technical documentation.
• Assist with FDA, TGA, EU MDR and other international regulatory programs.
• Coordinate documentation, testing reports and evidence required for submissions.
• Work with external regulatory consultants and testing laboratories.
• Track submission timelines, action items and regulatory deliverables.
• Assist with responses to regulatory questions and requests for additional information.
• Support regulatory compliance activities throughout the product lifecycle.

• Assist with planning and coordination of clinical and scientific evidence generation programs.
• Contribute to post-market clinical follow-up activities.

• Support design control activities including verification and validation documentation in collaboration with the Quality manager.
• Assist with risk management and product lifecycle documentation.
• Support internal and external audits as required.
• Collaborate closely with Quality, R&D and Commercial teams.

About You

• Degree in Biomedical Engineering, Medical Science, Life Sciences, Pharmacy, Biotechnology or related discipline.
• Approximately 5+ years’ experience in Regulatory Affairs, Clinical Affairs, Quality Assurance, or a related medical device role; previous experience in the orthopedic field is highly regarded.
• Working knowledge of medical device regulations including FDA, TGA, EU MDR and/or ISO 13485.
• Strong technical writing and documentation skills.
• Excellent organisational and project coordination abilities.
• Strong communication and stakeholder management skills.
• Ability to manage multiple projects and deadlines simultaneously.

• Ambitious with your career path and learning coaching opportunity.

Why Join SDIP Innovations?

• Be part of an Australian-developed medical technology with global impact.
• Work alongside experienced scientists, engineers and clinicians.
• Gain exposure to FDA and other international regulatory pathways and SDIP`s established mentors and advisors.
• Contribute directly to innovative products improving patient outcomes.
• Opportunity for professional growth as the company expands internationally.
• Collaborative and supportive team culture.
• Modern ISO-certified manufacturing and R&D facilities based in Sydney.